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Clinical Trial Summary

ART (Autologous Regeneration of Tissue) is a revolutionary technology for harvesting skin without the drawbacks of conventional grafting. This innovative system allows the clinician to collect hundreds of microcolumns of full-thickness skin tissue and apply them directly to the wound site. It can all be done in an outpatient setting with minimized donor site concerns.


Clinical Trial Description

Millions of Americans suffer from acute and hard-to-heal chronic wounds. The National Institutes of Health estimates that 3% of the U.S. population over the age of 65 has an open wound. As the population ages in concert with an increased incidence of diabetes and obesity, the problem will intensify. A recent article suggests that the financial burden of wound care is approaching 100 billion dollars. Despite the gravity of the problem and the number of patients afflicted, open wounds can take weeks, months or even years to heal. The search for interventions that promote healing, reduce suffering and enhance quality of life continues as does the need to address the underlying issues that disrupt the wound healing process. Countless hours are spent treating chronic wounds (diabetic ulcers, venous ulcers, pressure injuries). Called the "silent epidemic," chronic wounds often result in infection, disability and sometimes amputation. Crafting a treatment plan that addresses the individual needs of each wound and each patient, hinges on managing the underlying issues that can disrupt healing and increase healthcare costs. Innovation in wound bed preparation and tissue regeneration bring new hope for these patients in the form of more effective wound closure, improved quality of life and reduced costs. Autologous skin grafting is the gold standard for covering areas of skin loss.4 However, traditional grafting is limited by accessibility issues and donor site complications-pain, risk of infection, scarring. ART (Autologous Regeneration of Tissue) is a revolutionary technology for harvesting skin without the drawbacks of conventional grafting. This innovative system allows the clinician to collect hundreds of microcolumns of full-thickness skin tissue and apply them directly to the wound site. It can all be done in an outpatient setting with minimized donor site concerns. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05076578
Study type Interventional
Source SerenaGroup, Inc.
Contact
Status Completed
Phase N/A
Start date September 13, 2021
Completion date February 1, 2022

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